DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amed (US 7022100 B1) in view of Berg (US 5911715).
Regarding claim 1, Amed discloses an apparatus, comprising: a left-ventricular assist device, comprising: an impeller configured for insertion into a left ventricle of a heart of a subject (eg. Fig. 2-5, Col. 7, Ln. 55 – Col. 8, Ln. 44, blood pump 12 rotor 44 shaft 46 and impeller 48); a delivery tube configured to pass, through an aorta of the subject, from outside the subject into the left ventricle (eg. Col. 1, Ln. 45 – Col. 2, Ln. 3, Col. 17, Ln. 50-65), and a drive cable, which passes through the delivery tube and is configured to rotate the impeller so as to pump blood of the subject from the left ventricle into the aorta (eg. Col. 2, Ln. 45- Col. 2, Ln. 3, Col. 7, Ln. 10 – Col. 8, Ln. 15). Amed does not disclose the delivery tube comprising an outer layer that varies along a length of the delivery tube such that a flexural rigidity of the delivery tube at a first portion of the delivery tube, which is configured to traverse an aortic valve of the subject, is less than the flexural rigidity at a second portion of the delivery tube, which is configured to traverse at least a portion of an aortic arch of the subject, and the flexural rigidity at the second portion is less than the flexural rigidity at a third portion of the delivery tube, which is configured to traverse a descending aorta of the subject.
Berg teaches a catheter tube with an outer layer that has discrete tubular member segments having preselected flexibilities (Eg. Col. 13, Ln. 5-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Amed with the selective tube flexibilities as taught by Berg to provide the predictable result of maintaining the catheter’s ability to prevent guide catheter back-out and allowing for rigidity of a guiding catheter to be increased in a discrete segment (Eg. Berg, Col. 2, Ln. 35-46).
Regarding claim 4, the combined invention of Amed and Berg discloses the delivery tube comprises a uniform inner surface (Eg. Berg, Col. 6, Ln. 1-12).
Regarding claim 5, the combined invention of Amed and Berg discloses the outer layer has a variable composition along the length of the delivery tube (eg. Berg, claim 16 and 17).
Claim(s) 2-3, 6-7, 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amed (US 7022100 B1) in view of Berg (US 5911715), further in view of Stern (US 10926060 B2).
Regarding claim 2, the combined invention of Amed and Berg discloses the invention of claim 1, but does not disclose outer layer comprises a polyurethane jacket at the first portion of the delivery tube, a polyether block amide jacket at the second portion of the delivery tube, and a polyamide jacket at the third portion of the delivery tube.
Stern teaches a catheter that has portions that are made of polyether block amide, polyolefin elastomer, and polyurethane elastomer (Eg. Abstract, Col. 9 , Ln. 15-40, Col. 12, Ln. 42 – Col. 14, Ln. 12, Col. 18, Ln. 50 – Col. 19, Ln. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Amed and Berg with the materials as taught by Stern since the claimed materials are known materials in the art for use in catheters.
Regarding claim 3, the combined invention of Amed, Berg, and Stern discloses the flexural rigidity monotonically increases between the first portion of the delivery tube and the third portion of the delivery tube (eg. Stern, Col. 2, Ln. 39-45, gradient Col. 4, Ln. 53 – Col. 5, Ln. 7).
Regarding claim 6, the combined invention of Amed, Berg, and Stern discloses the outer layer has a variable thickness along the length of the delivery tube (eg. Stern, Col. 15, Ln. 55-62, Col. 16, Ln. 41-60, one of ordinary skill would have been able to change the diameter of the outer for the same concept of allowing the predictable result of adjusting stiffness).
Regarding claim 7, the combined invention of Amed, Berg, and Stern discloses the delivery tube further comprises a braid, which is inside the outer layer and has a pick density that varies along the length of the delivery tube such that the braid causes further variation in the flexural rigidity (eg. Stern, Col. 12, Ln. 1-20, Berg, Col. 6, Ln. 1-15).
Regarding claim 9, the combined invention of Amed, Berg, and Stern discloses the flexural rigidity at a distal end of the delivery tube is greater than the flexural rigidity at the first portion of the delivery tube (eg. Stern, Col. 4, Ln. 10-13, Col. 9, Ln. 15-40, Col. 12, Ln. 42 – Col. 14, Ln. 12, Col. 18, Ln. 50 – Col. 19, Ln. 5).
Regarding claim 10, the combined invention of Amed, Berg, and Stern discloses the flexural rigidity monotonically increases between the first portion of the delivery tube and the distal end of the delivery tube (eg. Stern, Col. 4, Ln. 10-13, Col. 9, Ln. 15-40, Col. 12, Ln. 42 – Col. 14, Ln. 12, Col. 18, Ln. 50 – Col. 19, Ln. 5).
Regarding claim 11, the combined invention of Amed, Berg, and Stern discloses the outer layer comprises a polyurethane jacket at the first portion of the delivery tube and a polyether block amide jacket at the distal end of the delivery tube (eg. eg. Stern, Col. 4, Ln. 10-13, Col. 9, Ln. 15-40, Col. 12, Ln. 42 – Col. 14, Ln. 12, Col. 18, Ln. 50 – Col. 19, Ln. 5).
Regarding claim 12, the combined invention of Amed, Berg, and Stern discloses the flexural rigidity at the distal end of the delivery tube is between the flexural rigidity at the first portion of the delivery tube and the flexural rigidity at the third portion of the delivery tube (eg. Stern, Col. 4, Ln. 10-13, Col. 9, Ln. 15-40, Col. 12, Ln. 42 – Col. 14, Ln. 12, Col. 18, Ln. 50 – Col. 19, Ln. 5, clause 25 and 28).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amed (US 7022100 B1) in view of Berg (US 5911715), further in view of Siess (US 11413446 B2).
Regarding claim 13, the combined invention of Amed and Berg discloses the invention of claim 1, but does not explicitly disclose the flexural rigidity at a fourth portion of the delivery tube, which is configured to span a point of insertion into a body of the subject, is less than the flexural rigidity at the third portion.
Siess teaches a stiffening structure that extends along the length of the catheter in a region along the catheter that is placed inside the patient’s body (eg. Col. 3, Ln. 5-31, Col. 4, Ln. 52 – Col. 5, Ln. 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Amed and Berg with the changing stiffness at certain surgical zones as taught by Siess to provide the predictable result of having better adjustability for different zones where more flexibility is needed.
Regarding claim 14, the combined invention of Amed, Berg, and Siess discloses flexural rigidity at a proximal end of the delivery tube is greater than the flexural rigidity at the fourth portion (Eg. Siess, Col. 4, Ln. 52 – Col. 5, Ln. 45).
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amed (US 7022100 B1) in view of Berg (US 5911715), further in view of Schaefer (US 6709429 B1).
Regarding claim 15, the combined invention of Amed and Berg discloses a tensile rigidity of the delivery tube is more uniform than the flexural rigidity of the delivery tube.
Schaefer teaches a catheter that uses axial members that hold tensile behavior constant (eg. Col. 2, Ln. 60 – Col. 3, Ln. 20, Col. 6, Ln. 44-60).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Amed and Berg to have a uniform tensile rigidity as taught by Schaefer to allow for the predictable result of preventing any stretching and shape deformation in a longitudinal direction during operation.
Regarding claim 16, the combined invention of Amed, Berg, and Schaefer discloses the delivery tube further comprises at least one fiber that extends along the length of the delivery tube and increases the tensile rigidity of the delivery tube, relative to if the delivery tube would not comprise the fiber (eg. Schaefer, Abstract, Col. 3, Ln. 19-31).
Regarding claim 17, the combined invention of Amed, Berg, and Schaefer discloses a tensile-rigidity ratio between the tensile rigidity at the second portion of the delivery tube and the tensile rigidity at the first portion of the delivery tube is less than a flexural-rigidity ratio between the flexural rigidity at the second portion of the delivery tube and the flexural rigidity at the first portion of the delivery tube (eg, Schaefer, Col. 2, Ln. 60 – Col. 3, Ln. 20, Col. 6, Ln. 44-60, one of ordinary skill would have arrived at tensile rigidity through routine optimization to arrive at a desired tension, see MPEP 2144.05).
Regarding claim 18, the combined invention of Amed, Berg, and Schaefer discloses a tensile-rigidity ratio between the tensile rigidity at the third portion of the delivery tube and the tensile rigidity at the second portion of the delivery tube is less than a flexural-rigidity ratio between the flexural rigidity at the third portion of the delivery tube and the flexural rigidity at the second portion of the delivery tube (eg, Schaefer, Col. 2, Ln. 60 – Col. 3, Ln. 20, Col. 6, Ln. 44-60, one of ordinary skill would have arrived at tensile rigidity through routine optimization to arrive at a desired tension, see MPEP 2144.05).
Regarding claim 19, the combined invention of Amed, Berg, and Schaefer discloses a tensile-rigidity ratio between the tensile rigidity at the third portion of the delivery tube and the tensile rigidity at the first portion of the delivery tube is less than a flexural-rigidity ratio between the flexural rigidity at the third portion of the delivery tube and the flexural rigidity at the first portion of the delivery tube (eg, Schaefer, Col. 2, Ln. 60 – Col. 3, Ln. 20, Col. 6, Ln. 44-60, one of ordinary skill would have arrived at tensile rigidity through routine optimization to arrive at a desired tension, see MPEP 2144.05).
Conclusion
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/MICHAEL J LAU/ Examiner, Art Unit 3796
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